U.S. patent number 4,530,366 [Application Number 06/443,889] was granted by the patent office on 1985-07-23 for electronic instrument for the control and treatment of infertility in women.
This patent grant is currently assigned to Ares N.V. Amsterdam NL, Swiss Branch. Invention is credited to Jacques Crausaz, Pierre Nessi.
United States Patent |
4,530,366 |
Nessi , et al. |
July 23, 1985 |
Electronic instrument for the control and treatment of infertility
in women
Abstract
A micro-computer-based instrument for characterizing a woman's
menstrual cycle by measuring her temperature (BBT) each day and
storing and analyzing those temperatures. The instrument defines,
with user interaction, a time window each day during which it will
accept a temperature measurement within a predetermined acceptable
temperature range taken with the aid of a thermistor temperature
probe than can be placed under the woman's tongue. The analysis
carried out on the collected temperature data includes comparing,
from the eighth day of a cycle, two average temperatures: M.sub.F
(average of a presumed follicular phase) and M.sub.L (average of a
presumed luteal phase). Comparison continues until the difference
between M.sub.L and M.sub.F exceeds a predetermined level thereby
defining a second phase of the cycle indicating that ovulation has
occured. After characterizing the cycle, the instrument indicates
the most appropriate days for hormone treatment, blood tests and
physician visits so that fertility treatment can be optimized.
Inventors: |
Nessi; Pierre (Geneva,
CH), Crausaz; Jacques (Fribourg, CH) |
Assignee: |
Ares N.V. Amsterdam NL, Swiss
Branch (Geneva, CH)
|
Family
ID: |
4329087 |
Appl.
No.: |
06/443,889 |
Filed: |
November 23, 1982 |
Foreign Application Priority Data
Current U.S.
Class: |
600/549;
374/E13.002; 600/551 |
Current CPC
Class: |
A61B
10/0012 (20130101); G01K 13/20 (20210101); A61B
2010/0019 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); G01K 13/00 (20060101); A61B
005/00 () |
Field of
Search: |
;128/736,738 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0147046 |
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Mar 1981 |
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DE |
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0110927 |
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Aug 1980 |
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JP |
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0110928 |
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Aug 1980 |
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JP |
|
2045480 |
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Oct 1980 |
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GB |
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Primary Examiner: Cohen; Lee S.
Assistant Examiner: Sykes; Angela D.
Attorney, Agent or Firm: Cushman, Darby and Cushman
Claims
What is claimed is:
1. A method for characterizing a woman's menstrual cycle for aiding
in the treatment of infertility comprising the steps of:
measuring and storing the woman's temperature on each of at least
the first eight days of a menstrual cycle;
disregarding the temperatures taken on days 1 to 3;
calculating the mean value M.sub.F of the temperatures taken on
days 4 and 5;
calculating the mean value M.sub.L of the temperatures taken on
days 6, 7 and 8;
determining the difference D=M.sub.F -M.sub.L ;
if D is greater than 0.3.degree. C., defining the first of the
three days forming the average M.sub.L as the day of ovulation;
if D is less than 0.3.degree. C., waiting for the next temperature
and recalculating D from the mean M.sub.L of the last three days of
the cycle that have been entered and an M.sub.F of all days
preceding the last three days used for the calculation of M.sub.L
and so on until D is greater than 0.3.degree. C.;
when D is greater than 0.3.degree. C., defining the antepenultimate
day of the cycle as the day of ovulation;
once the day of ovulation is determined, using a first
predetermined algorithm for processing temperature measurements
taken on days following the day defined as the day of ovulation,
this algorithm being characterized as follows: the average of the
follicular (post-menstrual) phase, taken as M.sub.F does not
change, however the average of the luteal phase (pre-menstrual
phase) taken as M.sub.L is calculated, using all of the days of the
cycle from the day defined as the ovulation day thereby changing
with each newly entered temperature, the ovulation day being
confirmed as the day of ovulation if D=M.sub.L -M.sub.F remains
above or equal to 0.2.degree. C. for at least three days; and if D
again becomes less than 0.2.degree. C. before the sixth day
following the day defined as the day of ovulation, using said first
algorithm or redefining the day of ovulation; and
in the event that the end of the cycle is reached without observing
or defining a day of ovulation, utilizing a second algorithm to
determine whether there exists a biphasic or monophasic cycle
according to the following mathematical scheme: the cycle is
arbitrarily divided into four equal parts I, II, III, and IV and
the average temperature of each of these four parts is calculated:
M.sub.I, M.sub.II, M.sub.III, and M.sub.IV ; these four average
temperatures then being compared with the overall average M of the
complete cycle to yield one of sixteen possible mathematical
combinations as set forth in the following table:
in the event of an irregular or monophasic curve, providing an
indication thereof; and
in the event of a biphasic curve, utilizing a third algorithm to
determine the ovulation day, said third algorithm comprising the
steps of:
determining the first daily temperature above a general average M
of temperatures over the complete cycle; defining this as a
temperature occurring on day P.sub.1 ;
starting from day P.sub.1, determining the next temperature below
M, this temperature being designated as occurring on day P.sub.2
;
if the different D=P.sub.2 -P.sub.1 is less than five days,
considering P.sub.1 as not being the day of ovulation and repeating
the process; and
if D=P.sub.2 -P.sub.1 is more than five days or if P.sub.2
coincides with the antepenultimate day, the penultimate day or the
last day of the cycle, considering P.sub.1 as the day of ovulation;
and
indicating the determined day of ovulation.
2. A method according to claim 1 further including the steps
of:
confirming a biphasic curve using said third algorithm; and using a
confirming fourth algorithm to check whether the day of ovulation
as determined is situated in a quadrant (+) with respect to M and
whether this quadrant is M.sub.III or M.sub.IV ; and
if both of these conditions are not satisfied, rejecting the day of
ovulation and providing an indication of an irregular curve.
Description
BACKGROUND OF THE INVENTION
This invention relates to an electronic instrument for measuring
and analyzing a woman's basal bodily temperature (BBT) in
connection with the treatment of infertility.
A normal menstrual cycle of a fertile woman is characterized by
basal body temperature (BBT) curve that is biphasic, i.e., there is
a rise in temperature a few hours after ovulation, a rise which
generally occurs at about the middle of the menstrual cycle.
AT the present time, the BBT curve is obtained by manually
measuring the woman's body temperature using a conventional
thermometer every morning upon rising. The temperatures are
manually plotted on a graph.
In cases of infertility the BBT curve is frequently abnormal. For
this reason a gynecologist usually begins the investigation of an
infertile patient by analyzing 2 or 3 cycles of the BBT.
In a certain number of cases of infertility, the BBT curve is not
biphasic but monophasic or irregular; this leads us to suppose that
ovulation is not occurring, or is occurring only intermittently.
Faced with this situation, as in a certain number of others, the
treatment adopted by the gynecologist includes hormone replacement
therapy with the object of initiating a normal menstrual cycle in
the patient, which would be characterized by a biphasic BBT
curve.
To achieve a certain efficacy, the hormone replacement therapy must
be given on certain precisely determined days throughout the
patient's cycle. The intervals between treatment days, and also the
interval between treatment and the observation of its results, must
also fall on precisely determined dates.
SUMMARY OF THE INVENTION
Therefore, there is provided a micro-processor based electronic
instrument for analyzing the BBT cycle and determining the
appropriate times for hormone replacement, blood tests, physician
observation, etc. The instrument includes a thermistor probe 11, a
temperature input circuit 54, a clock 41, an RAM memory 53 a
piezo-electric vibrator alarm 7, a continuous means for analysis of
the BBT curve of temperatures and an LCD display 31 for providing
analysis results to the user.
The instrument also includes means for prohibiting the acceptance
of more than one temperature each day within a morning time window,
and its acceptance only if the measured temperature falls between
35.0.degree. C. and 37.5.degree. C., and a system for replacing a
missing temperature, or too high a temperature (such as might occur
if the patient is running a fever), with the average temperature
for the two days adjacent to it.
The instrument also includes a system enabling the comparison, from
the 8th day of the cycle, of two average temperatures: M.sub.F
(average of the presumed follicular phase--days 4 and 5) and
M.sub.L (average of the presumed luteal phase--days 6, 7 and 8);
the first 3 days are not taken into account. This comparing
mechanism continues until D=M.sub.L -M.sub.F exceeds a
predetermined difference. When this predetermined difference is
reached, it is presumed that the cycle is in its second phase,
implying that ovulation has occurred; the antepenultimate day of
the cycle is then considered as the Estimated Time of
Ovulation--supposed (ETOs).
The instrument allows the patient suffering from infertility, and
needing hormone replacement therapy, and the gynecologist, to know
via the display (LCD), once the day for beginning treatment is
fixed, the days for taking hormones, the days for blood-tests the
day(s) for visiting the doctor, and the days forecast for maximum
fertility.
The present invention provides an instrument capable of measuring
the basal bodily temperature (BBT) automatically. The apparatus
stores each new daily temperature on up to 200 occasions (about 3
complete menstrual cycles). In addition, the instrument analyzes
the BBT curve in such a way as to detect a rise in temperature
indicative of ovulation. At the end of a menstrual cycle--entered
manually when the next menstrual period starts--the calculator
analyzes the monthly BBT curve as a whole and fixes, with the help
of a mathematical algorithm, referred to herein as algorithm no. 2,
an ovulation day which corroborates or refutes the day of ovulation
defined at the beginning of the daily temperature record. Then, in
cases in which ovulation is known and confirmed, the instrument
calculates and displays all individual temperatures, the length of
the cycle, the estimated day of ovulation and the lengths of the
post- and pre-menstrual phases. All these data are stored in the
computers and are used for forecasts of the following cycles.
Finally, when used in a mode T (hormonal treatment intended to
restart a normal menstrual cycle), the apparatus displays, from the
first day of treatment (fixed by the gynecologist) the days when
the hormone has to be taken and the days fixed for a visit to the
doctor for observation and/or blood tests.
The present invention thus provides electronic equipment for
measuring the BBT, including an NTC probe (thermistor) to obtain
the temperature, a temperature input circuit and a circuit to
transform the measured temperature into digital data bits, a
microprocessor for storage and processing of the information, and
an LCD display for displaying the results of analysis. The
instrument also has a clock which allows the day and the hour to be
displayed at any moment, and authorizes only one measurement of BBT
per day within a morning window predetermined by the patient. In
the BBT mode the instrument also defines a temperature window for
the acceptance of only temperatures within the range: 35.0.degree.
C.-37.5.degree. C.
BRIEF DESCRIPTION OF THE DRAWINGS
The presently preferred embodiment of the invention will be further
described with reference to a single figure, wherein:
FIG. 1 is a block diagram of the electronic instrument according to
the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The operation and function of the instrument will be described
first. Following that description, the hardware will be described
with reference to FIG. 1.
To measure the BBT the apparatus is attached to an NTC probe, the
tip of which is placed under the patient's tongue; the method of
use is as follows:
(i) The beginning of the first cycle is indicated on the equipment
by pressing code AAA (mode BBT) on the push-buttons of a keyboard
data entry device. This operation effects a general reset and the
display indicates that this day is day 1 of the cycle. This
operation, carried out on the first day upon waking, fixes the
"ideal" time for the daily measurement. Starting from this point,
the instrument itself fixes a daily window of 4 hours (2 hours each
side of the point) for the acceptance of a temperature reading.
From day 2 up to the end of the cycle a sound signal occurring at
the exact time of the point indicates to the patient that she has
to take a reading.
(ii) The NTC probe is placed in the mouth, under the tongue. As
soon as the temperature of the probe reaches a fixed threshold, the
instrument operates automatically and measures the BBT in a similar
way to that of a mercury thermometer (maximum thermometer). When
the temperature is accepted by the instrument, a sound signal
indicates to the patient that measurement is complete; the
instrument "goes to sleep again" automatically.
(iii) The temperatures of the first 3 days of the cycle are stored,
but are not taken into account in the analysis of the curve. The
calculator then accepts 5 more daily temperatures (days 4-5-6-7-8)
before beginning the analysis of the curve using an algorithm
referred to herein as algorithm no. 1. Once the temperature for day
8 is stored, the instrument calculates:
(1) M.sub.F =arithmetical average of days 4 and 5
(2) M.sub.L =arithmetical average of days 6-7 and 8
(3) D=M.sub.F -M.sub.L
If D>0.3, the first of the 3 days forming the average M.sub.L
(here, day 6) is taken to be the day of ovulation (0). If, on the
other hand, D<0.3, the calculator waits for the next temperature
and re-calculates D from the average (M.sub.L) of the last 3 days
of the cycle that have been entered (now 7-8-9) and that (M.sub.F)
of all the preceding days (now 4-5-6) and so on until D is greater
than 0.3.degree. C.
(iv) When D>0.3, the antepenultimate day of the cycle is taken
as the day of ovulation (day 0). Once day 0 is found, algorithm no.
2 is used for the following days: the average of the follicular
(post-menstrual) phase, taken as M.sub.F, does not change; on the
other hand the average of the luteal phase (pre-menstrual phase),
taken as M.sub.L, is then calculated using all the days of the
cycle from day 0, and thus changes with every newly entered
temperature. Day 0 is confirmed as the day of ovulation if
D=M.sub.L -M.sub.F remains above or equal to 0.2.degree. C. for at
least 3 days (that is to say 0+6). If D again becomes less than
0.2.degree. C. before day 0+6, algorithm no. 1 is used again, and
the search for an ovulation day begins again.
(v) If a day is missed, or if the temperature of one day is over
37.5.degree. C. (fever), the temperature for that day is replaced
by the average of the day preceding it and the day immediately
following it.
(vi) Using algorithms no. 1 and no. 2, it is possible to reach the
end of the cycle without observing or fixing a day of ovulation. In
such a situation, and only at the end of the cycle, the instrument
uses an algorithm referred to herein as algorithm no. 3 which,
having available all the temperatures of the cycle, proceeds to
seek a biphasic or monophasic cycle with the help of the following
mathematical scheme:
(1) The cycle is arbitrarily divided into 4 equal parts, I, II,
III, and IV, and the average temperature of each of these 4 parts
is calculated: M.sub.I, M.sub.II, M.sub.III and M.sub.IV. These 4
averages are then compared with the overall average of the cycle M.
There are then 16 possible mathematical combinations represented by
the following table:
______________________________________ M.sub.I M.sub.II M.sub.III
M.sub.IV No. Comments ______________________________________ + + +
+ 1 impossible + + + - 2 irregular or monophasic + + - + 3 biphasic
to be confirmed (M.sub.IV) + + - - 4 irregular/monophasic + - + - 5
biphasic to be confirmed (M.sub.III) + - - + 6 biphasic to be
confirmed (M.sub.IV) + - - - 7 irregular/monophasic + - + + 8
biphasic - + + + 9 biphasic - - + + 10 biphasic - + + - 11 biphasic
- - + - 12 biphasic to be confirmed (M.sub.III) - + - + 13 biphasic
to be confirmed (M.sub.IV) - - - + 14 biphasic - + - - 15
irregular/monphasic - - - - 16 impossible
______________________________________ + = M.sub.I, II, III or
.sub.IV above M - = M.sub.I, II, III, or .sub.IV below M
The extreme situations (1 and 16) are impossible. Situations
2-4-7-15 are very probably characteristic of irregular (monophasic)
curves. Situations 3-5-6-12-13 are perhaps biphasic but need a
confirming algorithm. Finally, situations 8-9-10-11-14 are very
probably biphasic.
(2) In cases where we are faced with an irregular or monophasic
curve (2-4-7-15) this is shown in the display for the attention of
the gynecologist; a new cycle can then be started without losing
information about the preceding cycle.
(3) In cases in which we are confronted with a biphasic curve
(8-9-10-11-14), algorithm no. 4 is used to find the ovulation day.
Moving along the cycle, we find the first daily temperature above
the general average, M, of the cycle: day P.sub.1. Then, starting
from day P.sub.1, we find the next 5 days, P.sub.1 is not
considered as the day of ovulation, 0, and the process of seeking
begins again. If, on the other hand, D=P.sub.2 -P.sub.1 is more
than 5 days or if P.sub.2 coincides with the antepenultimate, the
penultimate or the last day of the cycle, P.sub.1 is considered as
the day of ovulation.
(4) In cases in which we are faced with a biphasic curve to be
confirmed (3-5-6-12-13), algorithm no. 4 is used also. When the day
of ovulation 0 is found, a confirming algorithm 5 checks whether
the day of ovulation found is situated in a quadrant which is
"numbered" (+) with respect to M, and whether this quadrant is
M.sub.III or M.sub.IV. If both of these conditions are not
satisfied, day 0 is rejected and the phrase "irregular curve" is
displayed.
(vii) If the processor has observed a day 0 when the results are
fed in, it stores this information in its memory. At the end of the
cycle, it looks again for the day of ovulation, using algorithms 3
and 4, described under (vi). If this day 0 corresponds with the day
of ovulation (+or-2 days) found with the help of algorithms 1 and
2, then day 0 is definitely confirmed. In the contrary case, the
confirming algorithm no. 5 is used again to accept or reject the
ovulation day 0 (of point (4) paragraph (vi)).
(viii) If ovulation is definitively confirmed, it is possible to
show on the display: the length of the cycle, day 0 and take
lengths of the follicular and luteal phases. All these values are
stored in the memory for the purpose of forecasting future
cycles.
(ix) Where the curve is irregular or monophasic, the gynecologist
can try to establish a biphasic cycle by giving his patient
hormonal treatment. Given that hormonal treatment generally follows
a classic scheme, the instrument will indicate to the patient when
she has to take her hormonal treatment and when she has to go to
the doctor's for examination or blood test.
The instrument can also indicate, to a couple wishing to conceive,
which is the period of maximum fertility. This forecast uses the
information stored during previous cycles. The instrument also has
a normalized "series" output which enables the temperatures of the
cycle to be transferred to a more powerful computer, and thus a
more complete analysis of the curve to be carried out; or it allows
the temperatures to be printed on a pocket printer and the monthly
curve to be printed on it in summary.
The instrument can be used as a watch and a digital calendar, and
as a medical thermometer. Access to information is possible at any
moment by using special functions which do not alter the
functioning of the instrument as an electronic calculator used for
the treatment of infertility in women. It follows from the above
that the equipment can also be used in the field of family
planning.
Referring now to FIG. 1 (the sole FIGURE) there is shown a block
diagram of the electronic instrument according to the present
invention. The electronic instrument specially developed for the
control and treatment of infertility in women features a micro
computer integrated on a single silicon chip. The instrument
includes the following main elements and/or functions.
MEASUREMENT
A measuring probe 11 is provided for sensing the patient's
temperature. It comprises a resistor having a negative temperature
coefficient (NTC). The resistor is encapsulated in a protective
material that can be safely taken into the mouth. The probe
resistance forms an element of a Wheatstone measuring bridge 12. A
difference in potential 14 created by an imbalance of the bridge
across a bridge diagonal is converted to a binary number by the
analog-numerical converter 15 preferably of the type having a
double gradient.
This integrates, for a constant length of time, the bridge diagonal
potential difference 14 and then feeds its integrator with a
potential in proportion 13 to the feed potential of the bridge. As
a result a binary number 14 resulting from analog to numerical
conversion depends only on the resistances of the bridge. The
resistances of the bridge are chosen in such a way that
standardization only of the minimum point of the measuring range is
necessary. This standardization is carried out digitally with the
help of a binary input (16), the bridge having no variable
resistance.
Specifications:
measuring range 35.degree. C. to 40.degree. C.
resolution +0.05.degree. C.
absolute precision +0.1.degree. C.
CONTROL
A numerical keyboard 2 including twelve keys provides a means for
entering data and for causing the equipment to operate in a
selected one of its different modes of operation. The entry of data
or instructions through the keyboard is carried out by the keys
being pressed in sequence. Each command is represented by a code
which is displayed on a display screen.
DISPLAY
The instrument includes an alpha-numerical display (31) such as,
for example a liquid crystal display (LCD) connected with the
micro-computer via a display control (32) for carrying out
demultiplexing. It can display very clearly:
input or keyboard selection
the measured temperature
the readings of a clock
the results of analyses and the requisite treatment
CLOCK
The instrument includes an autonomous clock circuit (41) capable,
from a quartz crystal (43) of providing the processor or user, at
any moment, with the complete data and time. When the instrument is
functioning normally, the clock is used mainly for dating the daily
temperature readings which are accepted only within a four-hour
window. The clock also enables the patient to be told:
the time of the daily temperature reading, by a ring on a
piezo-electric vibrator
the daily actions to be carried out in the case of treatment
Clock 41 is powered by a battery 42 to ensure that the clock
functions without interruption.
MICRO-COMPUTER
As previously stated, the instrument features a micro-computer. The
micro-computer includes the following elements:
central processing unit 51 providing for the running of the
system
non-volatile memory 52 such as a PROM or a ROM containing the
program governing the functioning of the equipment and of the
treatment program as a whole
volatile memory 53 such as a RAM Memory 53 is preferably selected
to be a CMOS device, the supply voltage of which is kept constant
by the batteries of the supply system. This memory allows the
recording of the requisite treatment for infertility and of all
intermediate results generated from preceding analyses
communication units such as, for example, an input/output (I/O)
device 54 enabling all the peripheral elements to properly
interface with other micro-computer elements.
SERIES OUTPUT
Circuitry enables the user to transfer all the data contained in
the memory both to other calculators for a normalized series output
61 and to a thermic mini-printer symbolized by a printed document
62 so as to obtain a "hard" copy of the results of analysis.
PIEZO-ELECTRIC VIBRATOR
The instrument includes a piezo-electric vibrator 92 controlled by
the micro-computer, enabling the important events in the
functioning of the instrument to be acoustically signalled. These
events might include but not be limited to the following:
time of temperature reading
end of temperature reading
important event for treatment
ELECTRICAL SUPPLY
The electrical supply to the equipment is provided by a filtered
rectifier circuit 86 connected to a power supply such as commercial
power provided by a utility company. If the means should fail, if
it accidentally disconnected, or the device has to be moved, the
main functions (volatile memory and clock) are maintained by a
supply from the batteries 81 which are automatically charged by the
connection to the mains. If there is no mains supply, only a
certain number of important circuits are supplied; the others are
disconnected by means of a trip 85.
While the invention has been described in connection with what is
presently considered to be the most practical and preferred
embodiments, it is to be understood that the invention is not to be
limited to the disclosed embodiments but on the contrary, is
intended to cover various modifications and equivalent arrangements
included within the spirit and scope of the appended claims which
scope is to be accorded the broadest interpretation so as to
encompass all such modifications and equivalent structures.
* * * * *